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Study phase

I

During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

Study IDs

Site IRB

Rochester, Minnesota: 16-000798

NCT ID: NCT02754661

Sponsor Protocol Number: COVGIC20543

About this study

The purpose of this study is to compare the effectiveness of Colon Capsule Endoscopy versus Computed Tomographic Colonography for the screening of colon polyps in the usual screening population.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Subject is classified as average risk per the American Gastroenterological Association Guidelines on Colorectal Cancer Screening: Individuals without a personal or family history of CRC or adenomas, inflammatory bowel disease, or high-risk genetic syndromes.

Subject is willing and able to participate in the study procedures and to understand and sign the informed consent.

Exclusion Criteria:

Subject with history of colorectal cancer or adenoma (including those identified by computed tomography [CT], optical colonoscopy, sigmoidoscopy, etc.).

Subject with history of negative colonoscopy within 10 years, as these subjects would be defined as not requiring screening in this timeframe. For subjects with alternative screening methods, refer to applicable guidelines.

Subject with currently suspected or diagnosed with hematochezia, melena, iron deficiency with or without anemia, or any other rectal bleeding, including positive fecal occult blood test of any variety.

Subject with any current condition believed to have an increased risk of capsule retention such as suspected or known bowel obstruction, stricture, or fistula.

Subject with current dysphagia or any swallowing disorder.

Subject with current serious medical conditions that would increase the risk associated with CCE, CTC, or colonoscopy that are so severe that screening would have no benefit.

Subject with a cardiac pacemaker or other implanted electromedical device.

Subject expected to undergo MRI examination within 7 days after ingestion of the capsule.

Subject with clinical evidence of renal disease, including clinically significant laboratory abnormalities of renal function within the past 6 months, or at any time in the past if not tested within the last 6 months, defined as creatinine, blood urea nitrogen (BUN), and/or glomerular filtration rate (GFR) outside of the local laboratory reference range.

Subject with a diagnosis of gastroparesis or small bowel or large bowel dysmotility.

Subject with allergies or known contraindication to the medications or preparation agents used in the procedure as described in the relevant instructions for use.

Subject has an estimated life expectancy of less than 6 months.

Subject is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity).

Subject is pregnant, suspected pregnant, or is actively breast-feeding.

Females of child-bearing potential will be required to provide either a urine pregnancy test or serum pregnancy test as part of the participant's standard of care regardless of their participation in the study (except for subjects who are surgically sterile or are post-menopausal for at least two years).

Subject has participated in an investigational drug or device research study within 30 days of enrollment that may interfere with the subject's safety or ability to participate in this study.

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